Clinical trial · Interventional
Analysis of the Effectiveness of Neoadjuvant Chemotherapy in the Treatment of Colon Cancer Locally Advanced (ELECLA)
Analysis of the Effectiveness of Neoadjuvant Chemotherapy in the Treatment of Colon Cancer Locally Advanced
NCT04188158CI-TRIAL-00042073ELECLAunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Effectiveness analysis of neoadjuvant chemotherapy in the treatment of locally advanced colon cancer. ELECLA trial
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAPECITABINE AND OXALIPLATIN | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Group
- description
- 3 cycles XELOX + Surgery+ 5 cycles XELOX
- interventionNames
- Combination Product: CAPECITABINE AND OXALIPLATIN
- type
- OTHER
- label
- Control group
- description
- Surgery + 8 cycles XELOX
- interventionNames
- Combination Product: CAPECITABINE AND OXALIPLATIN
Primary outcomes (1)
- measure
- Disease-free survival (SLE) at 2 years
- timeFrame
- From the inclusion of the patient in the study to 5 years of follow-up or his death, whichever comes first.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * CLINICS 1. Histological confirmation of colon adenocarcinoma. 2. Patients of both sexes with age over 18 years. 3. Good general condition of the patient (Karnofsky\> 60% or ECOG (Eastern Cooperative Oncology Group) \<2). 4. Analytical at the time of inclusion with figures of Hemoglobin\> 10 g / dL; Leukocytes\> 3.0 109 / L, Platelets\> 100,000, Glomerular Filtration\> 50 ml / min and Total Bilirubin \<25 micromol / l. 5. Absence of contraindication for chemotherapy. 6. Acceptance and signature of the Informed Consent. * OF IMAGE 1. Radiological signs, evaluated by CT, of T4 or T3 tumor infiltration\> 5 mm of transmural invasion. 2. With or without lymph node involvement by CT. 3. No metastatic involvement in other organs (M0). 4. Radiologically resectable disease. REFERENCES TO THE TREATMENT <!-- --> 1. That they will undergo elective surgery with curative intent (R0). Exclusion Criteria: * 1\. Important comorbidity, uncontrolled angina or a history of acute myocardial infarction in the last 6 months. 2\. Personal history of another malignancy in the last 5 years, with the exception of melanoma. 3\. Uncontrolled infection 4. Pregnancy or lactation. 5. Peripheral neuropathy\> grade 1. 6. Rectum cancer (\<15 cm of the anal margin or below peritoneal reflection). 7. Presence of distant metastasis or peritoneal carcinomatosis. 8. Intestinal obstruction. 9. Existence of microsatellite instability 10. Refusal to participate or to give written consent 11. Impossibility, at the investigator's discretion, to understand the purpose of the study or to comply with its procedures.
References
Publications (1)
- DERIVEDArredondo J, Almeida A, Castanon C, Sanchez C, Villafane A, Tejedor P, Simo V, Baixauli J, Rodriguez J, Pastor C. The ELECLA trial: A multicentre randomised control trial on outcomes of neoadjuvant treatment on locally advanced colon cancer. Colorectal Dis. 2024 Apr;26(4):745-753. doi: 10.1111/codi.16908. Epub 2024 Feb 16. PMID 38362850